Technical Data Sheet

Preparation & Use Guidelines

Acryl-EZE 93A

Acryl-EZE® 93A series is a two-step, pigmented, aqueous, delayed release film coating system specifically designed to provide
enteric protection in elevated gastric pH environments. Acryl-EZE 93A series offers the formulator flexibility to select the
plasticizer type and level depending on the physicochemical properties of the pharmaceutical active or substrate. Combining the
benefits of a pigmented coating system with a globally accepted enteric polymer (EUDRAGIT® L100-55), Acryl-EZE 93A
formulations are easily dispersible in water, for the application of a delayed release film coating to solid dosage forms such as
tablets, granules and beads.

The coating system can be color matched to meet marketing requirements and the enteric coating provides consistent, reproducible
delayed release profiles.

Use Guidelines Mixing Procedure

ƒ Acryl-EZE 93A formulations are reconstituted to 20% w/w ƒ Determine the amount of Acryl-EZE 93A powder (to 20%
solids dispersion. w/w solids), plasticizer, water, and antifoam required,
ƒ The coating system is pigmented to meet marketing based on the quantity of tablets to be coated and the target
requirements and provides consistent, reproducible enteric coating weight.
protection and drug release. − Antifoam: 0.1 % w/w with respect to Acryl-EZE 93A
ƒ Recommended weight gains of Acryl-EZE 93A coatings powder
are 8% to 12% for enteric performance depending on the − Plasticizer: PEG 8000 (7-8% w/w), TEC (10-12%
physicochemical properties of the core. w/w) or Triacetin (12-13% w/w) with respect to
ƒ A sub-coat may be required to separate the active Acryl-EZE 93A powder
pharmaceutical ingredient from the enteric polymer or to
strengthen the dosage form prior to enteric coating. A ƒ Example To coat 1.0kg of tablets to 8% weight gain using
recommended subcoat formula is Opadry®, 03K19229. 10% triethyl citrate
ƒ A top-coat may be required for additional gloss or to aid in − 80.0g Acryl-EZE 93A powder
printing. − 8.0g TEC
− 320.0g Water
− 0.08g Simethicone
Preparation Guidelines
ƒ Weigh the water into the mixing vessel.
Materials ƒ Using a propeller stirrer, stir the water to form a vigorous
ƒ Acryl-EZE 93A formulated powder. vortex.
ƒ Distilled/deionised water at ambient temperature (20-35ºC). ƒ Weigh the antifoam and add it to the water.
ƒ Antifoam: simethicone or simethicone emulsion ƒ Weigh the plasticizer and add it to the water.
ƒ Plasticizer: triethyl citrate (TEC), polyethylene glycol ƒ Mix for 5 minutes.
(PEG) 8000, or triacetin ƒ Weigh the Acryl-EZE 93A powder and add it to the center
of the liquid vortex in a slow steady stream, avoiding
Equipment clumping and maintaining a vortex. After all of the
ƒ Variable speed mixer capable of producing and maintaining powder is added, decrease the stirring speed to eliminate
a vigorous vortex. the vortex and maintain sufficient mixing.
ƒ Mixing vessel, to contain a liquid volume one time greater ƒ Continue mixing for 30 minutes.
than the total suspension being prepared, to take account of ƒ Pass the dispersion through a 250 micron (60 mesh)
the slight initial foaming and mixing. screen prior to the coating process.
ƒ 250 micron (60 mesh) sieve. ƒ Ensure the dispersion is continuously stirred during the
coating process.
ƒ The suspension should be used the same day it is
prepared.
Acryl-EZE Clean Up Guidelines

For best results, clean equipment shortly after the end of the
coating run.

• Acryl-EZE residue remaining on the coating equipment can ƒ When cleaning spray guns, it is important to make sure
easily be removed using a mild (greater than pH 5.5) the passages are free of residual coating material that can
sodium bicarbonate solution. Sodium Bicarbonate block the orifice and restrict flow. A thin soft brush or
(NaHCO3) is regarded as an essentially non-toxic and non- swab can be passed through the tip of the gun to insure all
irritant material. Additionally, it is GRAS listed and has the coating material is removed. Avoid using hard
compendia status within the USP, BP, JP and PhEur. substances because these can damage the gun parts.
• Coating pans can be cleaned with a solution of NaHCO3 ƒ All equipment should be rinsed with deionised water after
and deionized water. If equipped, fill the pan reservoir with cleaning.
cleaning solution and allow the pan to rotate through the
solution for 30 minutes.
• Spray equipment (guns and hoses) should be disassembled
and can be soaked in the cleaning solution for 30 minutes.

Please contact your local Colorcon Technical Representative if you require any further information.
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Locations Telephone Facsimile Locations Telephone Facsimile

United States Asia/Pacific
Santa Ana, California 714-549-0631 714-549-4921 Singapore 65-6438-0318 65-6438-0178
Indianapolis, Indiana 317-545-6211 317-545-6218 Nishiyama, Japan 81-5-4465-2711 81-5-4465-2730
Humacao, Puerto Rico 787-852-3815 787-852-0030 Shanghai, China 86-21-5442-2222 86-21-5442-2229
Quebec, Canada 514-337-8341 514-337-9159 Goa, India 91-832-288-3434 91-832-288-3440
Seoul, Korea 82-2-2057-2713 82-2-2057-2179
Europe
Dartford, Kent, England 44-1322-293000 44-1322-627200 Latin America
Massy, France 33-1-6447-9750 33-1-6932-5983 Buenos Aires, 54-11-4552-1565 54-11-4552-3997
Argentina
Idstein, Germany 49-6126- 9961- 0 49- 6126-9961-11 Cotia, Brasil 55-11-4612-4262 55-11-4612-3307
Gallarate, Italy 39-0331-776932 39-0331-776831 Bogota, Colombia 571-418-1202 571-418-1257
Budapest, Hungary 36-1-200-8000 36 -1-200-8010 Santa Fe, Mexico 525-5-3000-5700 525-5-3000-5701
Barcelona, Spain 34-9-3589-3756 34-9-3589-3792 Caracas, Venezuela 58-212-442-4819 58-212-442-8724
Istanbul, Turkey 90-216-465-0360 90-216-465-0361

The information contained herein, to the best of our knowledge is true and accurate. Any recommendations or suggestions are made without warranty or guarantee, since the
conditions of use are beyond our control. Any information contained herein is intended as a recommendation for use of our products so as not to infringe on any patent.

© Colorcon, 2008. The information contained in this document is proprietary to Colorcon and may not be used or disseminated inappropriately.
Acryl-EZE® and Opadry® are registered trademark of BPSI Holdings Inc.
Eudragit® is a registered trademark of Röhm GmbH
mr/acryl-eze 93A/prep&use/03.08_rev1